BEUDAMED
    FDA Enforcement Class II Ongoing

    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

    Recall: Z-0519-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0519-2024
    Event ID
    93350
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 20, 2023
    Initiation Date
    October 19, 2023
    Classification Date
    December 8, 2023
    Address
    3471 River Hills Dr, N/A, Cincinnati, OH, 45244-3023, United States

    Description

    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

    Reason

    Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

    Code Info

    UDI-DI: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030

    Distribution

    Nationwide Foreign: Italy

    Quantity

    571 Cases